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Completed

NCT Number: NCT03203486

Response of NAFLD Patients to Mediterranean Diet

The effects of Mediterranean Diet (MedDiet) on clinical, biochemical and inflammatory profile in NAFLD patients with simple steatosis. Potential associations of single nucleotide polymorphisms to diet composition and patients' profile were also investigated.

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Key information

Conditions

NAFLD Digestive System Diseases Fatty Liver Inflammation Liver Diseases Non-alcoholic Fatty Liver Disease Pathologic Processes Pathological Conditions, Signs and Symptoms Steatosis of Liver

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Diet is a modifiable key factor targeted in prevention and management of non-alcoholic fatty liver disease (NAFLD). The aim of the study is to investigate the effect of Mediterranean Diet (MedDiet) on clinical, biochemical and inflammatory profile in NAFLD patients with simple steatosis. Potential associations of single nucleotide polymorphisms to diet composition and patients' profile are investigated. In this non-randomised, open-label study, 44 untreated NAFLD patients with non significant fibrosis receive nutritional counsel to increase adherence to MedDiet. Adherence to MedDiet is estimated with MedDietScore. Furthermore, genotyping of STAT3 rs2293152 and GCKR rs1260326 single nucleotide polymorphisms takes place.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • men and women >18y of age, no change in body weight (BW) for the last 6 months prior to the trial and body mass index (BMI) >25 kg/m2.

Exclusion criteria

  • the presence of chronic viral hepatitis, the presence of congenital or acquired liver disease, the history of prior exposure to hepatotoxic drugs, the evidence of hepatic cirrhosis, ultrasonography values less than 1Hz, bariatric surgery, daily consumption of ethanol more than 20g for women and more than 30g for men for over 6 months during the last 5 years, any medication effective on fatty liver disease introduced <6 months prior to or during the trial, the co-presence of a life-threatening disease, psychiatric disorders impairing the patient's ability to provide written informed consent, age>65 years, pregnant or lactating women, subjects supplemented with omega-3 polyunsaturated fatty acids, probiotics/synbiotics, antioxidant vitamins and/or phytochemicals, any planned, structured and repetitive physical activity. Patients with any medication change during the trial were excluded from analysis.

Treatment and study plan

Mediterranean Diet

Other

Participants were instructed to include vegetables, whole grains and fruits in their diet and increase fish, legumes and raw nut intake. Emphasis was given to extra virgin olive oil as the main added fat in meals. Particular attention was drained to decrease fermented dairy and poultry, with small amounts of red meat and homemade sweets. All participants were given meal plans in which the distribution of nutrients in relation to total caloric value was as follows: 40% of total energy as fat (50% as MUFAs), 20% as protein, 40% as carbohydrate, 300mg/d as dietary cholesterol and 20-30g fiber/d.

Primary outcomes

  1. Regulation of hepatic steatosis

    Time frame: Change from Baseline to 6 months

    A decrease in liver fat

Secondary outcomes

  1. Adherence to MedDiet

    Time frame: Change from Baseline to 6 months

    Increase in MedDietScore

  2. Regulation of visfatin

    Time frame: Change from Baseline to 6 months

    Decrease in visfatin levels

  3. Regulation of oxLDL

    Time frame: Change from Baseline to 6 months

    Decrease in oxLDL levels

  4. Association of single nucleotide polymorphisms to response to dietary treatment

    Time frame: Change from Baseline to 6 months

    Decrease in visfatin in carriers of the risk allele

Sponsors and collaborators

Lead sponsor

Harokopio University

Other

Collaborators

  • Greek Secretariat for Research and Technology
  • National and Kapodistrian University of Athens

Registry information

Official study title

The Effectiveness of a Mediterranean Diet Intervention in NAFLD Clinical Course

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 29, 2017
Registry last updated
Jun 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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